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Saturday, January 26, 2013

New Legislation Proposed In Oklahoma: But What's The Point Without More Inspectors and Actual Enforcement?

State Senator and compounding pharmacist
Rob Standridge pre-filed SB 522 bill in the Oklahoma Senate. SB 522 as written provides:

STATE OF OKLAHOMA

1st Session of the 54th Legislature (2013)

SENATE BILL 522 By: Standridge

AS INTRODUCED

An Act relating to nonresident pharmacies; requiring nonresident pharmacies to submit certain information in applications for license issuance or renewal; providing for certain fees; providing for codification; and providing an effective date.BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:SECTION 1. NEW LAW A new section of law to be codified in the Oklahoma Statutes as Section 355.3 of Title 59, unless there is created a duplication in numbering, reads as follows:As used in this act:1. "Nonresident pharmacy" means any pharmacy located outside of this state which delivers, dispenses, or distributes by any method prescription drugs or devices to a user physically located in this state, in addition to the initial application or renewal form and other documents required for a pharmacy located in Oklahoma; and2. "Pharmacist-in-charge" means a professionally competent, legally qualified pharmacist responsible for compliance with all Req. No. 367 Page 2laws and regulations governing the operation of the respective pharmacy.SECTION 2. NEW LAW A new section of law to be codified in the Oklahoma Statutes as Section 355.4 of Title 59, unless there is created a duplication in numbering, reads as follows:A nonresident pharmacy, in addition to the initial application or renewal form and other documents required for a pharmacy located in Oklahoma, shall:1. Submit an affidavit signed by the pharmacist-in-charge that the pharmacy shall comply with non-sterile and sterile compounding standards of the newest edition of the United States Pharmacopeial and United States Food and Drug Administration Good Manufacturing Practices;2. a. Submit a pharmacy site inspection form completed and signed within the previous eighteen (18) months by a person authorized by the pharmacy's resident state agency or board which is responsible for issuing pharmacy licenses,b. Submit a pharmacy site inspection form completed and signed within the previous eighteen (18) months by a staff person employed by the Oklahoma State Board of Pharmacy and pay all costs incurred by the Board for completion of the inspection, orReq. No. 367 Page 3c. Submit an inspection report or certificate of approval, from an organization approved by the Oklahoma State Board of Pharmacy, which shall include the standards and procedures to which the pharmacy demonstrated compliance; and3. Pay an additional fee of One Hundred Dollars ($100.00) over and above the licensing and inspection fees charged to in-state pharmacies to cover the additional costs associated with administrative review and consideration of documents listed in subparagraphs a, b and c of paragraph 2 of this section.SECTION 3. This act shall become effective November 1, 2013.54-1-367 JAM 1/25/2013 11:43:36 AM

The pre-filed bill would require non-resident
pharmacies to complete an affidavit stating their compliance
with USP standards and FDA Good Manufacturing Practices. Additionally,
non-resident pharmacies would need to submit current inspection reports from
their home state Board of Pharmacy and pay an additional fee for
renewal.While Standridge's bill is a start even if passed it will serve no purpose if there are not more and better inspections and enforcement of the laws and regulations. Anyone can sign an affidavit stating compliance with USP standards and FDA Good Manuafacturing Practices. What are the consequences for signing such an affidavit if it is false? And how does it work when the inspection in another state is based on different standards and laws than those in the state of Oklahoma? No problem if the other states' standards are higher, or is there? There is definitely a problem if the other state has lower inspection standards? Can you never do business in Oklahoma again if you submit a false affidavit? The bill provides no fine or consequences for failure to comply with the provisions. And is $100.00 really enough of an additional fee to charge out of state pharmacies who do business here? The bill provides for no additional funding at the Oklahoma State Board of Pharmacy. This also is another example of how complex and complicated the patchwork legislation can be for pharmacies to comply with in all states. This proposed legislation maybe a start in Oklahoma but is by no means a solution to the problems in the compounding world.As note that Oklahoma State Senator Bingman has written Senate Bill 250, addressing workers compensation program reimbursement whereby compounded medications
would be paid by the state's worker's compensation court at the rate of ingredient costs plus a $5.00
dispensing fee. Senate Bill 250 is a companion bill to pre-filed legislation in the
Oklahoma House -- HB 1546.

Tenth Circuit Standards of Review Manual, Western District of Oklahoma

Criminal Appeals Manual, Western District of Oklahoma

Creator, Author, and Presentor of Year in Review for Department of Justice United States Attorney's Office, Western District of Oklahoma

Other Blogs

www.thelawofveterinarymedicine.blogspot.com

www.oklahomapharmacylaw.blogspot.com

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